Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density

NCT ID: NCT02087436

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-12-31

Brief Summary

The primary purpose of this study is to measure the postoperative changes in bone mineral density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard length Taperloc Complete Reduced Distal stem.

Detailed Description

The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption. The primary aim of this study is therefore to compare the postoperative changes in bone density with the Taperloc Microplasty stem, using the standard length Taperloc stem as a control.

In addition, the Taperloc stem has historically had a neck angle of 138°. There have been criticisms that this neck angle is too high for the typical Korean population. The newer Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard stem in Korean Population

Conditions

Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis; Legg-Perthes Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Taperloc Complete Standard

Group one will receive a total hip replacement with Taperloc Complete Standard. Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Group Type: ACTIVE_COMPARATOR

Taperloc Complete Standard

Intervention Type: DEVICE

Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Taperloc Complete Microplasty

Group one will receive a total hip replacement with Taperloc Complete Microplasty.Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Group Type: ACTIVE_COMPARATOR

Taperloc Complete Microplasty

Intervention Type: DEVICE

Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Interventions

Taperloc Complete Microplasty

Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.

Intervention Type: DEVICE

Taperloc Complete Standard

Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients suitable for primary Total Hip Replacement

Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:

1. Osteoarthritis

2. Avascular necrosis

3. Legg Perthes

4. Rheumatoid Arthritis

5. Diastrophic variant

6. Fused hip

7. Sequelae of Slipped capital epiphysis

8. Traumatic arthritis

9. Patients aged over 20

10. Patients must be able to understand instructions and be willing to return for follow-up

Exclusion Criteria

• Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,

2. Small Femoral canal

2) Severe osteoporosis (Patients over 65 years old) 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. 8) pregnancy 9) Fracture of the pelvis 10) Subcapital fractures

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yong-Chan Ha, PHD

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Young-Kyun Lee, PHD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Chung-Ang University Hospital

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INT.CR.GH3.13

Identifier Type: -

Identifier Source: org_study_id